Data / Medical devices / Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase (CCK): 159 FDA-registered makers in 26 countries
159 establishments in 26 countries are registered with the FDA to make Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase (product code CCK, Class 2, 21 CFR 868.1400). 70 of them have a 510(k) clearance or PMA approval on file and 9 have a recall event. The FDA has issued 307 510(k) clearances under this code, the latest on August 12, 2026, and lists 36 recall events (4 Class I). FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Product code
- CCK
- Device class
- 2
- Regulation
- 868.1400
- Medical specialty
- Anesthesiology
Makers by country
| Country | Makers |
|---|---|
| United States | 59 |
| China | 27 |
| Mexico | 15 |
| Germany | 8 |
| Japan | 7 |
| United Kingdom | 6 |
| Malaysia | 5 |
| Sweden | 4 |
| Israel | 3 |
| Finland | 3 |
| India | 3 |
| Canada | 2 |
| Costa Rica | 2 |
| Taiwan | 2 |
| Singapore | 2 |
| Brazil | 1 |
| Turkey | 1 |
| Romania | 1 |
| Sri Lanka | 1 |
| Poland | 1 |
| South Korea | 1 |
| Ireland | 1 |
| France | 1 |
| Thailand | 1 |
| Estonia | 1 |
| Lithuania | 1 |
Makers of Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Oridion Medical 1987 Ltd. | Jerusalem, Israel | Manufacturer, Specification developer | 18 | July 29, 2022 | 0 | 7 | 0 | api.fda.gov |
| SunMed Group Holdings, LLC | Grand Rapids, MI, United States | Complaint file establishment, Specification developer | 15 | November 12, 2024 | 0 | 6 | 0 | api.fda.gov |
| Nihon Kohden America, Inc. | Irvine, CA, United States | Complaint file establishment, Manufacturer, Repackager or relabeler | 11 | June 10, 2025 | 0 | 2 | 0 | api.fda.gov |
| Nihon Kohden Corp. | SHINJUKU-KU Tokyo, Japan | Specification developer | 11 | June 10, 2025 | 0 | 0 | 0 | api.fda.gov |
| Nihon Kohden Corporation - Tokorozawa establishment Advanced Technology Center | Tokorozawa Saitama, Japan | Complaint file establishment, Specification developer | 10 | June 10, 2025 | 0 | 0 | 0 | api.fda.gov |
| Icu Medical, Inc. | San Clemente, CA, United States | Complaint file establishment, Specification developer | 8 | August 19, 2003 | 0 | 0 | 0 | api.fda.gov |
| Nihon Kohden Tomioka Production Center | TOMIOKA-SHI Gunma, Japan | Manufacturer | 6 | October 11, 2017 | 0 | 0 | 0 | api.fda.gov |
| Productos Urologos De Mexico S.A. De C.V. | MEXICALI Baja California, Mexico | Contract manufacturer, Manufacturer | 6 | June 20, 2018 | 0 | 0 | 0 | api.fda.gov |
| Mercury Medical Enterprises, LLC | Clearwater, FL, United States | Manufacturer | 5 | March 17, 2017 | 0 | 0 | 0 | api.fda.gov |
| Nihon Kohden Tomioka Corporation Nihon Kohden Kawamoto Production Center | Fukaya-Shi Saitama, Japan | Manufacturer | 5 | June 10, 2025 | 0 | 0 | 0 | api.fda.gov |
| Draegerwerk AG & Co. KGaA | LUEBECK Schleswig-Holstein, Germany | Contract manufacturer, Manufacturer, Specification developer | 4 | April 5, 2023 | 0 | 0 | 0 | api.fda.gov |
| Platinum Focus Group Ltd. | London London, City of, United Kingdom | Contract sterilizer, Exporter to the US, Manufacturer | 4 | May 1, 2019 | 0 | 0 | 0 | api.fda.gov |
| Salter Labs | El Paso, TX, United States | Specification developer | 4 | December 14, 2016 | 0 | 0 | 0 | api.fda.gov |
| Salter Labs de Mexico de S.A. de C.V. | Chihuahua Mexico, Mexico | Contract manufacturer, Manufacturer | 4 | December 14, 2016 | 0 | 0 | 0 | api.fda.gov |
| Flexicare Medical Ltd. | RHONDDA CYNON TAFF Wales, United Kingdom | Specification developer | 3 | April 30, 2014 | 0 | 0 | 0 | api.fda.gov |
| Nihon Kohden America Fulfillment Center | Foothill Ranch, CA, United States | Manufacturer, Repackager or relabeler | 3 | June 10, 2025 | 0 | 0 | 0 | api.fda.gov |
| Southmedic, Inc. | BARRIE Ontario, Canada | Manufacturer | 3 | November 21, 2023 | 0 | 2 | 0 | api.fda.gov |
| Spacelabs Healthcare Inc. | Snoqualmie, WA, United States | Manufacturer | 3 | March 21, 2013 | 0 | 1 | 0 | api.fda.gov |
| WESTMED de Mexico, S.A de C.V. | Tecate Baja California, Mexico | Manufacturer | 3 | December 14, 2016 | 0 | 0 | 0 | api.fda.gov |
| Westmed, Inc. | Tucson, AZ, United States | Contract manufacturer, Manufacturer, Specification developer | 3 | December 14, 2016 | 0 | 0 | 0 | api.fda.gov |
| Westmed Javid de Mexico, S.A. de C.V. | NOGALES Sonora, Mexico | Contract manufacturer, Manufacturer | 3 | December 14, 2016 | 0 | 0 | 0 | api.fda.gov |
| Beijing Kingst Medical Device Co., Ltd. | Beijing, China | Contract manufacturer, Manufacturer | 2 | May 22, 2020 | 0 | 0 | 0 | api.fda.gov |
| Covidien | TIJUANA, B.C. Mexico, Mexico | Manufacturer | 2 | September 17, 2021 | 0 | 0 | 0 | api.fda.gov |
| Covidien | Ciudad Juarez Chihuahua, Mexico | Manufacturer | 2 | March 22, 2019 | 0 | 0 | 0 | api.fda.gov |
| Covidien | Lafayette, CO, United States | Specification developer | 2 | September 17, 2021 | 0 | 3 | 1 | api.fda.gov |
| Draeger Medical Systems, Inc. | Andover, MA, United States | Complaint file establishment, Manufacturer | 2 | March 7, 2001 | 0 | 0 | 0 | api.fda.gov |
| Ge Healthcare Finland OY | HELSINKI Uusimaa, Finland | Manufacturer, Specification developer | 2 | October 21, 2021 | 0 | 0 | 0 | api.fda.gov |
| Industrial Vallera de Mexicali, S. A. de C. V. | Mexicali Mexico, Mexico | Manufacturer | 2 | March 29, 2021 | 0 | 0 | 0 | api.fda.gov |
| Masimo Corporation | Irvine, CA, United States | Complaint file establishment, Specification developer | 2 | March 29, 2021 | 0 | 0 | 0 | api.fda.gov |
| Philips Medical Systems Ltda | Varginha Minas Gerais, Brazil | Specification developer | 2 | January 12, 2006 | 0 | 0 | 0 | api.fda.gov |
| Philips North America LLC | Export, PA, United States | Contract manufacturer, Repackager or relabeler | 2 | December 14, 2016 | 0 | 0 | 0 | api.fda.gov |
| Respironics Novametrix, LLC | Andover, MA, United States | Specification developer | 2 | January 12, 2006 | 0 | 1 | 0 | api.fda.gov |
| Teleflex Medical LLC | Morrisville, NC, United States | Complaint file establishment, Specification developer | 2 | February 12, 2015 | 0 | 0 | 0 | api.fda.gov |
| Volcano Corporation by Volcarica S.R.L. | Coyol Alajuela, Costa Rica | Manufacturer | 2 | January 12, 2006 | 0 | 0 | 0 | api.fda.gov |
| Aei Technologies Inc. | Bastrop, TX, United States | Manufacturer | 1 | February 16, 1995 | 0 | 0 | 0 | api.fda.gov |
| Affirm Medical Technologies Ii, LLC | Piedmont, CA, United States | Complaint file establishment, Specification developer | 1 | July 14, 2026 | 0 | 0 | 0 | api.fda.gov |
| Applied Medical Technology, Inc. | Brecksville, OH, United States | Manufacturer | 1 | November 24, 2014 | 0 | 0 | 0 | api.fda.gov |
| AirLife Finland Oy | Helsinki Uusimaa, Finland | Complaint file establishment, Specification developer | 1 | April 30, 2018 | 0 | 0 | 0 | api.fda.gov |
| Barbaras Development, Inc. | Thousand Oaks, CA, United States | Manufacturer for export, Specification developer | 1 | June 4, 2025 | 0 | 0 | 0 | api.fda.gov |
| Bluepoint Medical GMBH & Co. KG | Selmsdorf Mecklenburg-Western Pomerania, Germany | Contract manufacturer, Manufacturer | 1 | December 18, 2019 | 0 | 0 | 0 | api.fda.gov |
| Besmed Health Business Corporation | New Taipei City, Taiwan | Exporter to the US, Manufacturer | 1 | February 5, 2015 | 0 | 0 | 0 | api.fda.gov |
| CMI Health, Inc. | Alpharetta, GA, United States | Specification developer | 1 | July 18, 2018 | 0 | 0 | 0 | api.fda.gov |
| Customed, Inc. | Fajardo, PR, United States | Manufacturer | 1 | October 3, 1989 | 0 | 0 | 0 | api.fda.gov |
| CareFusion 303, INC | San Diego, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | February 9, 2004 | 0 | 0 | 0 | api.fda.gov |
| CareFusion 303, INC. | San Diego, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | February 9, 2004 | 0 | 2 | 0 | api.fda.gov |
| ConvaTec Limited, GDC Building | Deeside Flintshire, United Kingdom | Specification developer | 1 | February 11, 1992 | 0 | 0 | 0 | api.fda.gov |
| Dispo-Med (malaysia) Sdn Bhd | Shah Alam Selangor, Malaysia | Manufacturer | 1 | February 13, 2015 | 0 | 0 | 0 | api.fda.gov |
| ICU Medical Healthcare Manufacturing S.A. de C.V. | Tijuana, B.C. C.P. Baja California, Mexico | Manufacturer | 1 | April 17, 1991 | 0 | 0 | 0 | api.fda.gov |
| Intersurgical Ltd. | Wokingham, Berkshire, United Kingdom | Specification developer | 1 | December 20, 2012 | 0 | 0 | 0 | api.fda.gov |
| Inventeur, LLC | Saint Petersburg, FL, United States | Specification developer | 1 | December 16, 2024 | 0 | 0 | 0 | api.fda.gov |
| Jaeger Medical GmbH | HOECHBERG Bavaria, Germany | Complaint file establishment, Manufacturer | 1 | October 12, 1984 | 0 | 0 | 0 | api.fda.gov |
| Medipines Corporation | Yorba Linda, CA, United States | Manufacturer, Specification developer | 1 | January 11, 2019 | 0 | 0 | 0 | api.fda.gov |
| Mediplus Ltd. | HIGH WYCOMBE, BUCKS Buckinghamshire, United Kingdom | Complaint file establishment, Exporter to the US, Specification developer | 1 | November 25, 2013 | 0 | 0 | 0 | api.fda.gov |
| MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, United States | Specification developer | 1 | January 22, 1993 | 0 | 0 | 0 | api.fda.gov |
| Meditera Tibbi Malzeme Sanayi ve Ticaret A.S. | Tire Izmir, Turkey | Manufacturer | 1 | January 17, 2020 | 0 | 0 | 0 | api.fda.gov |
| Nasorcap Medical, Inc. | Venetia, PA, United States | Manufacturer | 1 | August 14, 1992 | 0 | 0 | 0 | api.fda.gov |
| Ningbo Besmed Medical Equipment Corp. | NINGBO Zhejiang, China | Manufacturer | 1 | February 5, 2015 | 0 | 0 | 0 | api.fda.gov |
| Nonin Medical, Inc. | Plymouth, MN, United States | Manufacturer | 1 | August 12, 1999 | 0 | 0 | 0 | api.fda.gov |
| Nihon Kohden Tomioka Corporation | Gunma Tokyo, Japan | Manufacturer | 1 | July 25, 2002 | 0 | 0 | 0 | api.fda.gov |
| Orantech Inc. | Shenzhen Guangdong, China | Manufacturer | 1 | May 31, 2018 | 0 | 0 | 0 | api.fda.gov |
| Pneuma Therapeutics, Inc. | San Marcos, CA, United States | Specification developer | 1 | January 30, 2023 | 0 | 0 | 0 | api.fda.gov |
| Philips Medizin Systeme Boeblingen GmbH | BOEBLINGEN Baden-Wurttemberg, Germany | Complaint file establishment, Manufacturer, Specification developer | 1 | December 26, 2017 | 0 | 0 | 0 | api.fda.gov |
| Respironics Inc. | Murrysville, PA, United States | Complaint file establishment, Manufacturer | 1 | December 13, 2005 | 0 | 0 | 0 | api.fda.gov |
| Seebreath AB | Stockholm, Sweden | Specification developer | 1 | July 13, 2012 | 0 | 0 | 0 | api.fda.gov |
| Stryker Instruments | Portage, MI, United States | Complaint file establishment, Specification developer | 1 | April 19, 2018 | 0 | 0 | 0 | api.fda.gov |
| Tri-Anim Health Services, Inc. | Dublin, OH, United States | Specification developer | 1 | November 16, 2022 | 0 | 0 | 0 | api.fda.gov |
| Teleflex Medical de Tecate, S. de R.L de C.V. | TECATE Baja California, Mexico | Manufacturer | 1 | September 10, 1996 | 0 | 0 | 0 | api.fda.gov |
| Tylenol Medical Instruments Co., Ltd. | Zhongshan Guangdong, China | Contract manufacturer, Manufacturer | 1 | February 6, 2019 | 0 | 0 | 0 | api.fda.gov |
| Unimed Medical Supplies Inc | Shenzhen Guangdong, China | Manufacturer | 1 | March 4, 2021 | 0 | 0 | 0 | api.fda.gov |
| Vacumed, Div. Of Vacumetrics, Inc. | Ventura, CA, United States | Manufacturer | 1 | May 26, 1998 | 0 | 0 | 0 | api.fda.gov |
| Advanced Instrumentations, Inc. | Miami, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Athena GTX | Johnston, IA, United States | Complaint file establishment, Manufacturer, Remanufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Axcesor LLC | Menomonee Falls, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beijing Aeonmed Co., Ltd. | Sanhe Hebei, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bound Tree Medical, LLC | Grand Prairie, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Breas Medical AB | MOLNLYCKE Vastra Gotaland, Sweden | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Breas Medical, Inc. | N Billerica, MA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cadex Electronics, Inc. | RICHMOND British Columbia, Canada | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Caf Medical Solutions Inc | Hockley, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Celestica (romania) SRL | Bors Bihor, Romania | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Contec Medical Systems Co., Ltd | Qinhuangdao Hebei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Digicare Biomedical Technology, Inc. | Boynton Beach, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Draeger Interservices GmbH | Luebeck Schleswig-Holstein, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| EDAN Diagnostics, Inc. | San Diego, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Edan Instruments, Inc. | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Emi (dongguan) Asia Limited | Dongguan City Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Engineered Medical Systems, LLC | Bartlett, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Flexicare Medical (dongguan) Ltd. | DONGGUAN CITY Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Forefront (xiamen) Medical Devices Co., Ltd. | Xiamen Fujian, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Forefront Medical Technology (jiangsu) Co.,ltd | Changzhou Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fukuda Denshi Co., Ltd. | Shiroi-shi Chiba, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fukuda Denshi Co., Ltd. | Bunkyo-ku Tokyo, Japan | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Flash Global | Lockbourne, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Flexicare Lanka (Pvt) Ltd | Bandaragama Western, Sri Lanka | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Flextronics Manufacturing (Singapore) Pte Ltd | SINGAPORE South East, Singapore | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Freespira, Inc | Kirkland, WA, United States | Complaint file establishment, Manufacturer, Remanufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Frohe Sweden AB | Tyreso, Sweden | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gamamed Vascular Systems Inc. | Loveland, CO, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ge Medical Systems (china) Co., Ltd. | WUXI Jiangsu, China | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ge Medical Systems Information Technologies | El Paso, TX, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| GE Medical Systems Information Technologies - Critikon de Mexico S. de R.L. de C.V. | JUAREZ Chihuahua, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GE Medical Systems Information Technologies, Inc. | Waukesha, WI, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GE Medical Systems Information Technologies, Inc. | Wauwatosa, WI, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GPE MedTech Systeme GmbH | Dassow Mecklenburg-Western Pomerania, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangdong Biolight Meditech Co., Ltd | Zhuhai Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hosmed Inc. | Doral, FL, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Intersurgical Medical Apparatus (changzhou) Co., Ltd. | Changzhou City Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Industrial Vallera de Mexicali, S.A. de C.V. (Terra) | Mexicali Baja California, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Intersurgical Medical Sdn. Bhd. | Simpang Ampat Pulau Pinang, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangyin Sinbon Electronics Co Ltd | Jiangyin Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| KB Components Finland Oy | Nurmijarvi Etela-Karjala, Finland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kimball Electronics Poland Sp.z o.o | Tarnowo Podgorne Wielkopolskie, Poland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mediana Co., Ltd. | Wonju-Si, Gangwon-do, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medisize Ireland Ltd. | LETTERKENNY Donegal, Ireland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MINDRAY DS USA, Inc. | Mahwah, NJ, United States | Complaint file establishment, Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Masimo Medical Technologies (Malaysia) SDN BHD | Pasir Gudang Johor, Malaysia | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MedDev Manufacturing Sdn Bhd | Klang Selangor, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Shengyurui Medical Appliance Co. | Ningbo Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Xinwell Medical Technology Co., Ltd. | Cixi Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| NextPhase Medical Devices Mexico LLC | TIJUANA Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Osi Optoelectronics (medical Division) | Hawthorne, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Osi Systems Pvt Ltd(optoelectronics Division) | HYDERABAD Telangana, India | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Oricare Inc. | Quakertown, PA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Physio-Control, Inc. | Redmond, WA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Plaxtron Industrial (M) Sdn. Bhd. | IPOH Perak, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| POM Medical, LLC | Moorpark, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| PROTOTAL Sweden AB | Jonkoping, Sweden | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pulsion Medical Systems Se | Aschheim, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Philips France | Paris, France | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Philips Goldway (Shenzhen) Industrial Inc. | SHENZHEN Guangdong, China | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Philips North America LLC | Cambridge, MA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Philips North America LLC | Andover, MA, United States | Specification developer | 0 | 0 | 2 | 0 | api.fda.gov | |
| Philips North America LLC | Murrysville, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Polimeros Formula de Tecate S.A de C.V | Tecate Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Quasar Medical (Thailand) Co., Ltd | Chonburi Chon Buri, Thailand | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| RAUMEDIC Estonia AS | Tallinn Harjumaa, Estonia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Remote Diagnostic Technologies Ltd. | FARNBOROUGH Hampshire, United Kingdom | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Repair Operations Center | Oak Creek, WI, United States | Remanufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sanmina- Sci Israel Medical Systems Ltd. | Maalot-Tarshiha Northern, Israel | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Comen Medical Instruments Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Creative Industry Co., Ltd | SHENZHEN Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Skanray Technologies Limited | Mysore Karnataka, India | Complaint file establishment, Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SMC Costa Rica Division S.R.L. | El Coyol Alajuela, Costa Rica | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Suzhou Jingle Polymer Medical Apparatus Co., Ltd. | SUZHOU Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Salaera, LLC d.b.a Maxtec | Salt Lake City, UT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sanmina-SCI Systems Singapore Pte. Ltd. | SINGAPORE North East, Singapore | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Mindray Bio-Medical Electronics Co.,LTD | SHENZHEN Guangdong, China | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Siemens Healthineers AG | FORCHHEIM Bavaria, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sistemas Medicos Alaris S.A de C.V. | Tijuana Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Technical Services for Electronics, Inc. | New Taipei City, Taiwan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| UAB Intersurgical | PABRADE Svencionys, Lithuania | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Usr Electronic Systems (1987) Ltd | Karmiel Northern, Israel | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vincent Medical (dong Guan) Manufacturing Co., Ltd. | Dong Guan City Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wipro Ge Medical Device Manufacturing Private Limited | Bangalore Karnataka, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Westmed de Mexico, S.A de C.V | NOGALES Sonora, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhongshan Hongze Medical Technology Co., Ltd. | Zhongshan Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zoll Medical Corporation | Chelmsford, MA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated August 12, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.